Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
150529–150552 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 14, 1985
MARTANIQUE 7-TUBE RUVA HOME SOLARIUM
K845028 · FTC
Bainbridge Trading Co., Ltd.
General & Plastic Surgery · 18d
Cleared Jan 14, 1985
SOLAR TAN - SOLARIA IV
K850042 · FTC
Sola-Tan Intl.
General & Plastic Surgery · 7d
Cleared Jan 10, 1985
HORIZON ECG SYSTEM
K823844 · DSI
Beckman Instruments, Inc.
Cardiovascular · 751d
Cleared Jan 10, 1985
MULTILITH PULSE GENERATORS, 1141 & 2141
K842193 · DXY
Ela Medical, Inc.
Cardiovascular · 220d
Cleared Jan 10, 1985
CEREGROTRAC
K842784 · GWQ
Advanced Instruments, Inc.
Neurology · 177d
Cleared Jan 10, 1985
HEARING AID, UNITRON UE12-PP
K843245 · ESD
Unitron Industries, Inc.
Ear, Nose, Throat · 143d
Cleared Jan 10, 1985
COFIELD SHOULDER SYSTEM
K843624 · KWS
Richards Medical Co., Inc.
Orthopedic · 122d
Cleared Jan 10, 1985
ROD FOR RACHIS SURGERY
K843687 · KWP
Sofamor Co.
Orthopedic · 114d
Cleared Jan 10, 1985
I.V. START KIT & OBSTETRICAL KIT
K843724 · KKX
E.M. Adams
General Hospital · 108d
Cleared Jan 10, 1985
POROUS COATED TITANIUM KNEE PROSTHES-
K843907 · JWH
Johnson & Johnson Professionals, Inc.
Orthopedic · 99d
Cleared Jan 10, 1985
INTRAVASCULAR BLOOD GAS SYSTEM
K843912 · CCE
Cardiovascular Devices, Inc.
Anesthesiology · 99d
Cleared Jan 10, 1985
STIMTECH SD CLINICIAN 6090 #78-8055
K844212 · GZJ
Codman & Shurtleff, Inc.
Neurology · 71d
Cleared Jan 10, 1985
STIMTECH SD PATIENT 6089 #78-8050
K844213 · GZJ
Codman & Shurtleff, Inc.
Neurology · 71d
Cleared Jan 10, 1985
NOVAMETRIX 811 TRANSCO2M PORTABLE TRANSCUTANEOUS 2
K844253 · KLK
Novametrix Medical Systems, Inc.
Anesthesiology · 69d
Cleared Jan 10, 1985
L100D PATIENT CIRCUIT DUAL LINE
K844290 · BZO
Life Products, Inc.
Anesthesiology · 66d
Cleared Jan 10, 1985
VIVALITH II 301 PULSE GENERATOR
K844334 · DXY
Pacesetter Systems
Cardiovascular · 64d
Cleared Jan 10, 1985
SURE & NATURAL MAXISHIELDS W/SUPERABSORBENT
K844342 · HHD
Personal Products Co.
Obstetrics & Gynecology · 63d
Cleared Jan 10, 1985
MODEL 78210A TELEMETRY TRANSMITTER
K844376 · DRG
Hewlett-Packard Co.
Cardiovascular · 58d
Cleared Jan 10, 1985
ESOPHAGEAL STETHOSCOPE
K844444 · BZW
Medical Parameters, Inc.
Anesthesiology · 55d
Cleared Jan 10, 1985
FUKUDA DENSHI MODEL FCP-220
K844470 · DPS
Brentwood Instruments, Inc.
Cardiovascular · 52d
Cleared Jan 10, 1985
GENERAL PURPOSE INSTRUMENT TRAYS SUTURE REMOVAL TR
K844613 · FSM
Packaging Technologies, Inc.
General & Plastic Surgery · 44d
Cleared Jan 10, 1985
GOWNS, SURGICAL
K844703 · FYA
Medicon, Inc.
General Hospital · 38d
Cleared Jan 10, 1985
CAPS (O.R. NURSE, SURGICAL)
K844704 · FYF
Medicon, Inc.
General & Plastic Surgery · 38d
Cleared Jan 10, 1985
SHOE COVERS
K844705 · FXP
Medicon, Inc.
General Hospital · 38d